The FDA’s priority review pathway is getting a workout.
Regulators agreed to give Sage Therapeutics $SAGE a quick 6-month review for IV brexanolone (SAGE-547) — the FDA’s third priority move in two days — which it hopes will go on to become its first marketed drug. And this one could be headed to a huge market, if the FDA approves it for postpartum depression, a condition that afflicts a significant minority of women after giving birth.
The target date for Sage’s drug is December 19, but first the FDA will put the drug through an expert panel assessment with a public inspection of an internal review on the table.
Sage has already won a breakthrough therapy designation for their drug, which could offer a big leg up in marketing if it’s OK’d. And that’s not a slam dunk.
While Sage scored a positive outcome against PPD in two relatively small Phase III studies, their drug — provided through an infusion that takes 60 hours to complete — didn’t do as well as it did in in Phase II, with the big gap that separated the drug and placebo arms narrowing significantly.
The main goal of both studies was a significant reduction in depression scores 60 hours after treatment. And on that level the drug scored a 17.7-point mean reduction for the high dose and a 19.9-point improvement for the low dose in the first study for severe PPD compared to 14 points in the placebo arm. In study two there was a 14.2-point vs 12-point difference in the moderate PPD group.
In Phase II, researchers reported a 12.2-point spread between the drug and the placebo, leaving Sage defending a significantly reduced margin of improvement. And there were mixed results on durability as well.
RBC’s Brian Abrahams has pegged peak potential sales at about $650 million, factoring in a price of $15,000 to $20,000 per infusion — if it gets the green light. And analysts have shown considerable enthusiasm for an oral follow-up that could overcome the infusion hurdle.
This new priority review comes a day after Loxo and Bayer gained the same pathway for larotrectinib, the same day Astellas bagged its own 6-month snap inspection for their AML drug. Regulators have been turning to priority reviews more frequently as FDA commissioner Scott Gottlieb delivers on his promise to speed things up for drug developers.
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